A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects

NCT03767504 | Unknown

• 1 other identifier: INNV-MS1000-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Number of Participants with adverse events as a measure of tolerance

  Day 60 (End of Study)

• Change in creatinine kinase

  Change in creatinine kinase measured in U/L

  Day 1(Baseline) to Day 60 (End of Study)

• Change in myostatin levels

  Change in myostatin will be measured by blood samples using ELISA method.

  Day 1(Baseline) to Day 60 (End of Study)

Secondary Outcomes (3)

• Changes in weight

  Day 1(Baseline) to Day 60 (End of Study)

• Change in cholesterol levels

  Day 1(Baseline) to Day 60 (End of Study)

• Number, type, and severity of adverse events

  60 days

Study Arms (1)

Musclin

EXPERIMENTAL

Thymol based dietary supplement

Dietary Supplement: Thymol

Interventions

Thymol DIETARY_SUPPLEMENT

Musclin - a dietary supplement: 2 capsules (20 mg thymol per capsule) BID with a meal for 30 days increased to 4 capsules for an additional 30 days.

Also known as: Musclin

Musclin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer \> 40 years (adult)
• Systolic blood pressure 90-140 mmHg upon screening
• Subject has provided written informed consent
• Subject is willing to undergo the procedures outlined in this study
• Subjects BMI is within 18-28.
• Subjects of childbearing potential must use a hormonal method of birth control, single-barrier method or a double-barrier method of birth control throughout the study or be documented as medically sterile.

You may not qualify if:

• Subject has clinically significant deviation from normal in any organ system.
• Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
• Pregnant, breastfeeding, or planned pregnancy during the study duration.
• Known liver, renal or muscle diseases.
• History of hypertensive or currently taking anti-hypertensive medications.
• Presence or history of specific heart conditions.
• Currently taking anti-thyroid or thyroid replacement medications.
• Currently taking any creatinine kinase lowering drug or supplement.
• Use of investigational drug within the previous 30 days.
• Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
• Known allergies or intolerance to ingredients in Musclin™
• Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.

Sponsors & Collaborators

• Innovus Pharmaceuticals, Inc.: lead

Study Sites (1)

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

RECRUITING

MeSH Terms

Interventions

Thymol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Monoterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm, ascending dose

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: November 13, 2018
• Primary Completion: February 13, 2019
• Study Completion: February 28, 2019
• Last Updated: December 6, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)